Standard

BS EN ISO 15195:2019

Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures

Current, Under Review

•

Published:

28 Feb 2019

1 Scope

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.

The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This document is not applicable to medical laboratories.

NOTE Requirements for medical laboratories are specified in ISO 15189^[¹^].

Product Details

Descriptors

Quality assurance

Quality management

Working conditions (physical)

Management operations

Personnel management

Contracting

Laboratories

Laboratory equipment

Clinical medicine

Specimen preparation

Test specimens

Reference conditions

ICS Codes

11.100.01 Laboratory medicine in general

11.100.99 Other standards related to laboratory medicine

Committee

CH/212

International relationships

Identical to:

EN ISO 15195:2019

ISO 15195:2018

ISBN

978 0 580 92238 1

Publisher

BSI